Adopting a Physically Active Lifestyle Through Organized Walk Events Among Joslin Clinic Patients

• ClinicalTrials.gov Identifier: NCT01888133
• Recruitment Status: Terminated
• First Posted: June 27, 2013
• Last Update Posted: April 3, 2014
• Sponsor: Joslin Diabetes Center
• Information provided by (Responsible Party): William Hsu, Joslin Diabetes Center

Tracking Information

• First Submitted Date: April 2, 2013
• First Posted Date: June 27, 2013
• Last Update Posted Date: April 3, 2014
• Study Start Date: April 2013
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 25, 2013): Change in steps/day [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 25, 2013)

• Change in BMI [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]
• Change in Blood Pressure [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]
• Change in Waist Circumference [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]
• Hip Circumference [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]
• Change in Physical Activity Pattern [ Time Frame: Baseline, Week 6, Week 12 ]
• Change in Food Consumption [ Time Frame: Baseline, Week 6, Week 12 ]
• Change in Fructosamine [ Time Frame: Baseline, Week 6, Week 12 ]
• Change in Pulse [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]
• Change in Height [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]
• Change in Weight [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]
• Change in A1c [ Time Frame: Baseline, Week 12 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Adopting a Physically Active Lifestyle Through Organized Walk Events Among Joslin Clinic Patients
• Official Title: Adopting a Physically Active Lifestyle Through Organized Walk Events Among Joslin Clinic Patients
• Brief Summary: Can participation in group physical activity, such as a community-based organized group walk, help adult diabetes patients develop a physically active lifestyle? Can such engagement ultimately lead to an improvement in hemoglobin A1c? To address this question, the investigators have designed this pilot study with the aim to investigate the effect of community-based group walks among Joslin adults with diabetes on the development of a physically active lifestyle and glycemic level. The investigators hypothesize that participation in group walking events helps Joslin adults with diabetes engage in physical activity and improves glycemic control.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label)

Condition

• Diabetes
• Physical Activity

Intervention

• Behavioral: Group Walk
  weekly walking club session on Saturday mornings at Boston Common, lasting 30 min - 1 hour and engage in daily physical activity (aiming for 10,000 steps/day or increase number of steps by 500 every 2 weeks)
• Behavioral: Individual Walk
  engage in daily physical activity (aiming for 10,000 steps/day or increase number of steps by 500 every 2 weeks)

Study Arms

• Experimental: Group Walk First
  Participants attend a weekly walking group session from weeks 1-6 and are not required to attend from weeks 7-12.
  Interventions:

  • Behavioral: Group Walk
  • Behavioral: Individual Walk
• Experimental: Individual Walk First
  Participants are not required to attend a weekly group walking sessions from weeks 1-6 and attend a weekly walking group session from weeks 7-12.
  Interventions:

  • Behavioral: Group Walk
  • Behavioral: Individual Walk

Publications *

• Tudor-Locke C, Bell RC, Myers AM, Harris SB, Ecclestone NA, Lauzon N, Rodger NW. Controlled outcome evaluation of the First Step Program: a daily physical activity intervention for individuals with type II diabetes. Int J Obes Relat Metab Disord. 2004 Jan;28(1):113-9.
• Ford ES, Herman WH. Leisure-time physical activity patterns in the U.S. diabetic population. Findings from the 1990 National Health Interview Survey--Health Promotion and Disease Prevention Supplement. Diabetes Care. 1995 Jan;18(1):27-33.
• Hays LM, Clark DO. Correlates of physical activity in a sample of older adults with type 2 diabetes. Diabetes Care. 1999 May;22(5):706-12.
• Tudor-Locke CE, Bell RC, Meyers AM. Revisiting the role of physical activity and exercise in the treatment of type 2 diabetes. Can J Appl Physiol. 2000 Dec;25(6):466-92. Review.
• Manson JE, Hu FB, Rich-Edwards JW, Colditz GA, Stampfer MJ, Willett WC, Speizer FE, Hennekens CH. A prospective study of walking as compared with vigorous exercise in the prevention of coronary heart disease in women. N Engl J Med. 1999 Aug 26;341(9):650-8.
• Kang M, Marshall SJ, Barreira TV, Lee JO. Effect of pedometer-based physical activity interventions: a meta-analysis. Res Q Exerc Sport. 2009 Sep;80(3):648-55.
• Merom D, Rissel C, Phongsavan P, Smith BJ, Van Kemenade C, Brown WJ, Bauman AE. Promoting walking with pedometers in the community: the step-by-step trial. Am J Prev Med. 2007 Apr;32(4):290-7. Epub 2007 Feb 15.
• Kahn EB, Ramsey LT, Brownson RC, Heath GW, Howze EH, Powell KE, Stone EJ, Rajab MW, Corso P. The effectiveness of interventions to increase physical activity. A systematic review. Am J Prev Med. 2002 May;22(4 Suppl):73-107. Review.
• American Diabetes Association. Executive summary: Standards of medical care in diabetes--2012. Diabetes Care. 2012 Jan;35 Suppl 1:S4-S10. doi: 10.2337/dc12-s004.
• Januszewski AS, Karschimkus C, Davis KE, O'Neal D, Ward G, Jenkins AJ. Plasma 1,5 anhydroglucitol levels, a measure of short-term glycaemia: assay assessment and lower levels in diabetic vs. non-diabetic subjects. Diabetes Res Clin Pract. 2012 Jan;95(1):e17-9. doi: 10.1016/j.diabres.2011.09.032. Epub 2011 Oct 22.
• Barrett-Connor E. Nutrition epidemiology: how do we know what they ate? Am J Clin Nutr. 1991 Jul;54(1 Suppl):182S-187S. doi: 10.1093/ajcn/54.1.182S. Review.
• Löwe B, Kroenke K, Gräfe K. Detecting and monitoring depression with a two-item questionnaire (PHQ-2). J Psychosom Res. 2005 Feb;58(2):163-71.
• Tudor-Locke C, Bassett DR Jr. How many steps/day are enough? Preliminary pedometer indices for public health. Sports Med. 2004;34(1):1-8. Review.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 1, 2014): 22
• Original Estimated Enrollment (submitted: June 25, 2013): 44
• Actual Study Completion Date: April 2014
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Joslin Clinic patients
• 18 years or older
• A1C between 7.5% - 12.0%
• Received physician clearance indicating safe to participate in the walk club events
• Reside within Boston and Greater Boston Area
• Ability to communicate in English and/or Chinese
• Agree to participate in the intervention walk club for 6 consecutive weeks

Exclusion Criteria:

• Pregnant or breast feeding
• Unstable angina or myocardial infarction within 1 month prior to screening
• Unstable gait, severe neuropathy, or deformed foot.
• Enrolled in another investigational study within 1 month prior to screening for this study
• On medications such as prednisone that will affect blood glucose

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01888133
• Other Study ID Numbers: CHS 2012-12
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: William Hsu, Joslin Diabetes Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Joslin Diabetes Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: William Hsu, MD; Joslin Diabetes Center

• PRS Account: Joslin Diabetes Center
• Verification Date: April 2014